Many processes require sterile samples of a fluid to be obtained from within a process conduit without either the sample or the fluid within the conduit being contaminated with biological activity. Processes that may require such sterile sampling include microbiological and chemical monitoring, biopharmaceutical manufacturing, other chemical processes, and decontamination systems.
Verification of whether a decontamination process was effective is important for the sterilization of medical instruments. A typical decontamination process consists of a treatment/decontamination cycle or cycles followed by a rinse cycle or cycles using sterile water. Whether a decontamination process is successful may be determined by assessing the degree to which any biological activity exists in the rinse water. In this respect, samples of the rinse water from the final rinse cycle may be obtained and incubated to determine whether the rinse water contains any biological activity. If the sample of rinse water contains biological activity, it may be assumed that the decontamination cycle was ineffective. If the sampling method introduces biological activity or contamination into the sample, then misleading results may be obtained. Obtaining a liquid sample without introducing any biological activity into the sample is therefore essential to determining whether a decontamination process was effective.
Fluid samples may be taken from a conduit to be sampled by many methods. A typical apparatus for obtaining sterile samples provides valves that allow a sample to be withdrawn from a conduit and then allow the conduit to be resealed without contaminating the conduit. One problem with these systems is that they require flushing in order to maintain sterility.
The present invention overcomes this and other problems and provides an assembly to be installed within a system conduit for obtaining, under sterile conditions, a fluid sample from a process stream within the conduit.